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FDA Clearance Granted for Blood Tissue Monitor

Blood bag (NIH)

(National Institutes of Health)

Ornim Inc. in Santa Clarita, California said it received clearance from the U.S. Food and Drug Administration (FDA) to market its the CerOx 3210F monitor. The FDA action, known as a 510(k) clearance, is a pre-market notification required for medical devices to be sold in the U.S.

Ornim says the FDA action clears the CerOx 3210F monitor for use as a non-invasive monitor of blood flow in tissue of adults. The device has already been cleared for for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle.

A 510(k) submission, named after the applicable section of FDA’s enabling legislation, demonstrates that the device to be marketed is at least as safe and effective — substantially equivalent — to a device that is already legally marketed. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

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